A Study of Coformulated Favezelimab/Pembrolizumab (MK-4280A) Versus Physician's Choice Chemotherapy in PD-(L)1-refractory, Relapsed or Refractory Classical Hodgkin Lymphoma (MK-4280A-008)
- Conditions
- Hodgkin Lymphoma
- Interventions
- Registration Number
- NCT05508867
- Lead Sponsor
- Merck Sharp & Dohme LLC
- Brief Summary
Researchers are looking for a way to treat classical Hodgkin lymphoma (cHL) that is relapsed (the cancer has come back after treatment) or refractory (current treatment has stopped working to slow or stop cancer growth). Researchers want to learn if people who receive coformulated favezelimab/pembrolizumab (MK-4280A) live longer without the cancer getting worse compared to those who receive chemotherapy.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 200
- Has histologically confirmed diagnosis of classical Hodgkin lymphoma (cHL) that is 2-fluorodeoxyglucose-avid (FDG-avid).
- Has relapsed (defined as disease progression after most recent therapy) or refractory (defined as failed to achieve CR or PR to most recent therapy) cHL and exhausted all available treatment options with known clinical benefit.
- Has progressed on treatment with an anti-PD-(L)1 monoclonal antibody (mAb) administered either as monotherapy or in combination with other checkpoint inhibitors or other therapies.
- Submits an archival (≤5 years) or newly obtained tumor tissue sample which has not been previously irradiated.
- Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy.
- History of central nervous system (CNS) metastases or active CNS involvement.
- Has an active autoimmune disease that has required systemic treatment in past 2 years except replacement therapy.
- History of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.
- Has an active infection requiring systemic treatment.
- History of hemophagocytic lymphohisticytosis.
- Has an active seizure disorder that is not well controlled.
- Has clinically significant (ie, active) cardiovascular disease.
- Received prior systemic anticancer therapy including investigational agents within 4 weeks before randomization.
- Received prior radiotherapy within 2 weeks of start of study intervention or radiation related toxicities requiring corticosteroids.
- Has not adequately recovered from major surgical procedure.
- Known additional malignancy that is progressing or has required active treatment within the past 3 years.
- History of human immunodeficiency virus (HIV).
- Has had an allogeneic hematopoietic stem cell or solid organ transplantation within the last 5 years.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Favezelimab/Pembrolizumab favezelimab/pembrolizumab Participants will receive coformulated favezelimab/pembrolizumab (800 mg/200 mg) by intravenous (IV) infusion on Day 1, then every three weeks (Q3W), for up to 35 infusions. Chemotherapy (Bendamustine or Gemcitabine) bendamustine Participants will receive physician's choice of EITHER bendamustine by IV infusion at a dose between 90 and 120 mg/m\^2 on Day 1 and Day 2 of either a 3- or 4-week cycle for up to 6 cycles OR gemcitabine by IV infusion at a dose between 800 and 1200 mg/m\^2 on Day 1 and Day 8 of a 3-week cycle for up to 6 cycles. Chemotherapy (Bendamustine or Gemcitabine) gemcitabine Participants will receive physician's choice of EITHER bendamustine by IV infusion at a dose between 90 and 120 mg/m\^2 on Day 1 and Day 2 of either a 3- or 4-week cycle for up to 6 cycles OR gemcitabine by IV infusion at a dose between 800 and 1200 mg/m\^2 on Day 1 and Day 8 of a 3-week cycle for up to 6 cycles.
- Primary Outcome Measures
Name Time Method Progression Free Survival (PFS) per Lugano Response Criteria as Assessed by investigator Up to approximately 39 months PFS is defined as the time from randomization to the first documented disease progression per Lugano criteria 2014 as assessed by investigator or death due to any cause, whichever occurs first.
- Secondary Outcome Measures
Name Time Method Overall Survival (OS) Up to approximately 39 months OS is defined as the time from randomization to death due to any cause.
Objective Response Rate (ORR) per Lugano Response Criteria as Assessed by investigator Up to approximately 39 months ORR is defined as the percentage of participants who achieve a complete response (CR) or partial response (PR) per Lugano criteria 2014 as assessed by investigator.
Duration of Response (DOR) per Lugano Response Criteria as Assessed by investigator Up to approximately 39 months For participants who demonstrate CR or PR per Lugano criteria 2014 as assessed by investigator, DOR is defined as the time from the first documented evidence of CR or PR until disease progression or death due to any cause, whichever occurs first.
Number of Participants Who Experienced At Least One Adverse Event (AE) Up to approximately 25 months An AE is any untoward medical occurrence in a clinical study participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who experience an AE will be presented.
Number of Participants Who Discontinue Study Treatment Due to an Adverse Event (AE) Up to approximately 24 months An AE is any untoward medical occurrence in a clinical study participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who discontinue study treatment due to an AE will be presented.
Trial Locations
- Locations (105)
Sun Yat-sen University Cancer Center ( Site 0500)
🇨🇳Guangzhou, Guangdong, China
The University of Arizona Cancer Center - North Campus ( Site 2216)
🇺🇸Tucson, Arizona, United States
UCLA Hematology/Oncology - Santa Monica ( Site 2208)
🇺🇸Los Angeles, California, United States
Lundquist Institute for Biomedical Innovation at Harbor-UCLA-Hematology and Medical Oncology ( Site
🇺🇸Torrance, California, United States
Moffitt Cancer Center ( Site 2200)
🇺🇸Tampa, Florida, United States
University of Kentucky Chandler Medical Center ( Site 2201)
🇺🇸Lexington, Kentucky, United States
University of Maryland-Greenebaum Comprehensive Cancer Center ( Site 2210)
🇺🇸Baltimore, Maryland, United States
Johns Hopkins University-The Sidney Kimmel Comprehensive Cancer Center ( Site 2206)
🇺🇸Baltimore, Maryland, United States
University of Michigan ( Site 2215)
🇺🇸Ann Arbor, Michigan, United States
Cancer and Hematology Centers of Western Michigan ( Site 2222)
🇺🇸Grand Rapids, Michigan, United States
Rutgers Cancer Institute of New Jersey ( Site 2217)
🇺🇸New Brunswick, New Jersey, United States
Roswell Park Cancer Institute ( Site 2220)
🇺🇸Buffalo, New York, United States
University Hospitals Cleveland Medical Center ( Site 2214)
🇺🇸Cleveland, Ohio, United States
Cleveland Clinic-Taussig Cancer Center ( Site 2203)
🇺🇸Cleveland, Ohio, United States
AHN West Penn Hospital ( Site 2213)
🇺🇸Pittsburgh, Pennsylvania, United States
UPMC Hillman Cancer Center ( Site 2205)
🇺🇸Pittsburgh, Pennsylvania, United States
Fred Hutchinson Cancer Center ( Site 2212)
🇺🇸Seattle, Washington, United States
Hospital Aleman-oncohematologic diseases ( Site 2302)
🇦🇷Buenos Aires, Argentina
Fundacion Centro Oncologico de Integración Regional-Medical Oncology ( Site 2301)
🇦🇷Mendoza, Argentina
The Townsville Hospital ( Site 0006)
🇦🇺Townsville, Queensland, Australia
Royal Adelaide Hospital ( Site 0005)
🇦🇺Adelaide, South Australia, Australia
Western Health-Sunshine & Footscray Hospitals-Cancer Services-Cancer Research ( Site 0002)
🇦🇺St Albans, Victoria, Australia
Royal Perth Hospital-Haematology ( Site 0004)
🇦🇺Perth, Western Australia, Australia
UZ Leuven-Hematology ( Site 0101)
🇧🇪Leuven, Vlaams-Brabant, Belgium
Université Catholique de Louvain-Namur - Centre Hospitalier Universitaire Dinant-Godinne - Site Godi
🇧🇪Namur, Belgium
Fundação Pio XII - Hospital de Câncer de Barretos ( Site 0202)
🇧🇷Barretos, Sao Paulo, Brazil
Hospital Paulistano-Americas Oncologia ( Site 0207)
🇧🇷Sao Paulo, Brazil
Cross Cancer Institute ( Site 0313)
🇨🇦Edmonton, Alberta, Canada
Princess Margaret Cancer Centre ( Site 0310)
🇨🇦Toronto, Ontario, Canada
Jewish General Hospital ( Site 0309)
🇨🇦Montreal, Quebec, Canada
McGill University Health Centre ( Site 0314)
🇨🇦Montréal, Quebec, Canada
FALP-UIDO ( Site 0400)
🇨🇱Santiago, Region M. De Santiago, Chile
Clínica Inmunocel ( Site 0407)
🇨🇱Santiago, Region M. De Santiago, Chile
Anhui Provincial Cancer Hospital ( Site 0501)
🇨🇳Hefei, Anhui, China
Beijing Hospital ( Site 0514)
🇨🇳Beijing, Beijing, China
Peking University Third Hospital-Hematology ( Site 0519)
🇨🇳Beijing, Beijing, China
The First Affiliated hospital of Xiamen University ( Site 0512)
🇨🇳Xiamen, Fujian, China
Henan Cancer Hospital ( Site 0515)
🇨🇳Zhengzhou, Henan, China
Union Hospital Tongji Medical College Huazhong University of Science and Technology ( Site 0509)
🇨🇳Wuhan, Hubei, China
Fakultni nemocnice Hradec Kralove-IV. interni hematologicka klinika ( Site 0902)
🇨🇿Hradec Kralove, Czechia
Xiangya Hospital Central South University ( Site 0513)
🇨🇳Changsha, Hunan, China
Hunan Cancer Hospital ( Site 0503)
🇨🇳Changsha, Hunan, China
The First Hospital of Jilin University-Hematology ( Site 0516)
🇨🇳Changchun, Jilin, China
Fudan University Shanghai Cancer Center ( Site 0520)
🇨🇳Shanghai, Shanghai, China
West China Hospital of Sichuan University-Head and Neck Oncology ( Site 0502)
🇨🇳Cheng Du, Sichuan, China
Tianjin Medical University Cancer Institute & Hospital-lymphoma ( Site 0506)
🇨🇳Tianjin, Tianjin, China
Zhejiang Cancer Hospital ( Site 0510)
🇨🇳Hangzhou, Zhejiang, China
Ningbo First Hospital ( Site 0518)
🇨🇳Ningbo, Zhejiang, China
Fakultní nemocnice Brno Bohunice-Interni hematologicka a onkologicka klinika ( Site 0901)
🇨🇿Brno, Brno-mesto, Czechia
Vseobecna fakultni nemocnice v Praze-I. Interní klinika - klinika hematologie ( Site 0903)
🇨🇿Praha 2, Czechia
Centre Hospitalier Universitaire de Rennes - Hôpital Pontchaillou-haematology ( Site 0707)
🇫🇷Rennes, Bretagne, France
Institut Universitaire du Cancer Toulouse - Oncopole - CHU de TOULOUSE ( Site 0706)
🇫🇷Toulouse, Haute-Garonne, France
Centre Hospitalier Universitaire de Limoges - Hôpital Dupuytren ( Site 0704)
🇫🇷Limoges, Haute-Vienne, France
Institut Curie - site Saint-Cloud ( Site 0708)
🇫🇷Saint-Cloud, Hauts-de-Seine, France
CENTRE LEON BERARD-Medical oncology ( Site 0703)
🇫🇷Lyon, Rhone, France
HENRI MONDOR HOSPITAL ( Site 0702)
🇫🇷Créteil, Seine-et-Marne, France
Klinikum Stuttgart - Katharinenhospital ( Site 0804)
🇩🇪Stuttgart, Baden-Wurttemberg, Germany
Universitaetsklinikum Ulm-Department of Internal Medicine III ( Site 0805)
🇩🇪Ulm, Baden-Wurttemberg, Germany
Universitaetsklinikum Essen ( Site 0807)
🇩🇪Essen, Nordrhein-Westfalen, Germany
Universitaetsklinikum Koeln-Klinik I für Innere Medizin ( Site 0801)
🇩🇪Köln, Nordrhein-Westfalen, Germany
Universitätsklinikum Münster - Albert Schweitzer Campus ( Site 0806)
🇩🇪Münster, Nordrhein-Westfalen, Germany
Universitaetsklinikum Carl Gustav Carus Dresden-University Cancer Center Early Clinical Trial Unit (
🇩🇪Dresden, Sachsen, Germany
Universitätsklinikum Leipzig ( Site 0803)
🇩🇪Leipzig, Sachsen, Germany
Rambam Health Care Campus ( Site 1004)
🇮🇱Haifa, Israel
Carmel Hospital ( Site 1007)
🇮🇱Haifa, Israel
Hadassah Medical Center-Hemato-Oncology ( Site 1000)
🇮🇱Jerusalem, Israel
Rabin Medical Center-Hemato-Oncology ( Site 1001)
🇮🇱Petah-Tikva, Israel
Sheba Medical Center-Hemato Oncology ( Site 1005)
🇮🇱Ramat Gan, Israel
Sourasky Medical Center ( Site 1002)
🇮🇱Tel Aviv, Israel
Pusan National University Hospital-Internal Medicine ( Site 1704)
🇰🇷Busan, Pusan-Kwangyokshi, Korea, Republic of
Seoul National University Hospital ( Site 1701)
🇰🇷Seoul, Korea, Republic of
Severance Hospital, Yonsei University Health System-Medical oncology ( Site 1702)
🇰🇷Seoul, Korea, Republic of
Asan Medical Center-Department of Oncology ( Site 1703)
🇰🇷Seoul, Korea, Republic of
Samsung Medical Center ( Site 1700)
🇰🇷Seoul, Korea, Republic of
Centro de Infusion Superare ( Site 2503)
🇲🇽Ciudad de México, Distrito Federal, Mexico
Unidad Médica Onco-hematológica ( Site 2507)
🇲🇽Puebla, Mexico
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckieg-Klinika Hematologii, Nowotworów Krwi i
🇵🇱Wrocław, Dolnoslaskie, Poland
Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie-Oncology Department ( Site 1406)
🇵🇱Kraków, Malopolskie, Poland
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Kilinka Onkologii I Hematologii ( Site
🇵🇱Warszawa, Mazowieckie, Poland
Uniwersyteckie Centrum Kliniczne-Klinika Hematologii i Transplantologii ( Site 1402)
🇵🇱Gdansk, Pomorskie, Poland
Swietokrzyskie Centrum Onkologii, Samodzielny Publiczny Zakl-Klinika Hematologii i Transplantacji S
🇵🇱Kielce, Swietokrzyskie, Poland
Hospital Universitario Marqués de Valdecilla ( Site 1805)
🇪🇸Santander, Cantabria, Spain
Hospital Universitari Vall d'Hebron ( Site 1803)
🇪🇸Barcelona, Cataluna, Spain
CHUAC-Complejo Hospitalario Universitario A Coruña ( Site 1812)
🇪🇸A Coruña, La Coruna, Spain
Hospital Insular de Gran Canaria-Oncology ( Site 1807)
🇪🇸Las Palmas de Gran Canaria, Las Palmas, Spain
Hospital General Universitario de Alicante ( Site 1806)
🇪🇸Alicante, Spain
Hospital Universitario 12 de Octubre-Hemathology and hemotherapy ( Site 1810)
🇪🇸Madrid, Spain
Hospital Universitario Virgen de la Victoria ( Site 1808)
🇪🇸Malaga, Spain
Hospital Universitario de Salamanca - Complejo Asistencial U-Servicio de Hematologia ( Site 1801)
🇪🇸Salamanca, Spain
Skånes Universitetssjukhus Lund ( Site 1901)
🇸🇪Lund, Skane Lan, Sweden
Akademiska sjukhuset-Blod- och tumörsjukdomar ( Site 1900)
🇸🇪Uppsala, Uppsala Lan, Sweden
Ospedale Regionale Bellinzona e Valli-IOSI ( Site 1600)
🇨🇭Bellinzona, Ticino, Switzerland
Mega Medipol-Hematology ( Site 2005)
🇹🇷Stanbul, Istanbul, Turkey
Ankara Universitesi Tip Fakultesi Hastanesi-hematology ( Site 2000)
🇹🇷Ankara, Turkey
Hacettepe Universite Hastaneleri-Department of Hematology ( Site 2006)
🇹🇷Ankara, Turkey
Antalya Egitim ve Arastırma Hastanesi ( Site 2011)
🇹🇷Antalya, Turkey
Ege Universitesi Hastanesi ( Site 2001)
🇹🇷İzmir, Turkey
Kocaeli Üniversitesi-Hematology ( Site 2009)
🇹🇷Kocaeli, Turkey
Derriford Hospital ( Site 2107)
🇬🇧Plymouth, Devon, United Kingdom
The Beatson West of Scotland Cancer Centre ( Site 2110)
🇬🇧Glasgow, Glasgow City, United Kingdom
St Bartholomew's Hospital-Centre for Experimental Cancer Medicine ( Site 2105)
🇬🇧London, London, City Of, United Kingdom
GenesisCare - Oxford ( Site 2104)
🇬🇧Oxford, Oxfordshire, United Kingdom
St James's University Hospital ( Site 2109)
🇬🇧Leeds, United Kingdom
Leicester Royal Infirmary ( Site 2100)
🇬🇧Leicester, United Kingdom
Clatterbridge Cancer Centre - Liverpool-Heamatology ( Site 2108)
🇬🇧Liverpool, United Kingdom